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1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed: and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

9. Rheumatoid arthritis.

10. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

11. Failed osteotomies, unicompartmental replacement, or total knee replacement.

12. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;
2. Correction of functional deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
· Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
· Correction of functional deformity;
· Revision procedures where other treatments or devices have failed; and
· Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

1. Degenerative arthritis in the distal femur and patella;
2. A history of patellar dislocation or patellar fracture; and
3. Failed previous surgery (arthroplasty, tibial tubercule elevation, lateral release) where pain, deformity or dysfunction persists.
   The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

9. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

10. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The Legion Hinge Knee System is for Cemented Use Only.

11. Rheumatoid arthritis.

12. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

13. Failed osteotomies, unicompartmental replacement, or total knee replacement.

14. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

15. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

16. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement.

These devices are indicated for patients with:

1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
2. Previous tibial condyle or plateu fractures with loss of anatomy or function.
3. Varus or Valgus deformities.
4. Revision of previous arthroplasty procedures.
   The devices are indicated for cemented use only.
   The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
• Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
• As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
  The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

Total Knee components are indicated for:

1. Rheumatoid arthritis
2. Post- traumatic arthritis, osteoarthritis, or degenerative arthritis
3. Failed osteotomies, unicompartmental replacement, or total knee replacement
4. The posterior stabilized knee system is designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
   The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling (instructions for use, product labeling and patient implant card) of the subject Smith & Nephew Knee Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. As these products have been in distribution for several years, some parts have undergone changes in the technological characteristics that were assessed in compliance with the FDA's guidanceon "Deciding When to Submit a 510(k) for a Change to an Existing Device" or the FDA predecessor guidance on how to review changes to an existing device. These are not cumulative changes for all Smith & Nephew Knee Systems, but are rather specific changes that only affect certain parts. In the context of this submission, no modifications have been made to the device design, materials, sterilization, or the manufacturing process of the previously cleared devices due to the addition of MR Labeling for this 510(k).

The provided text describes a 510(k) premarket notification for various Smith & Nephew knee systems. The purpose of this submission is not to introduce a new device or significantly change an existing one that would require a new performance study to demonstrate clinical effectiveness or safety based on patient outcomes. Instead, the core of this submission is to add MR safety information to the labeling of existing, already cleared devices.

Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic or AI-driven devices (which you are asking about) are not applicable to this 510(k) submission.

The "performance data" section in the document, despite its heading, refers specifically to Magnetic Resonance Imaging (MRI) compatibility testing, not clinical performance of the knee implants themselves. This testing aims to demonstrate that the presence of the knee implants does not pose an undue risk or create excessive artifacts during MRI scans.

Here's why the questions you asked cannot be fully answered or are not relevant to this specific regulatory submission:

• No new device performance for clinical outcomes: This submission isn't about proving a device (like an AI algorithm) is effective at diagnosing or treating a condition. It's about ensuring an existing physical implant is safe in an MRI environment.
• No diagnostic or AI algorithm: The "device" in question here is a knee implant, not a software algorithm that generates clinical insights or diagnoses. Therefore, terms like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth," or "training set" are not applicable.

However, I can extract the relevant information regarding the MR safety testing which serves as the "study" for this particular 510(k) submission:

Acceptance Criteria and Study for MR Safety Labeling (as described in the document):

Since this 510(k) is specifically for adding MR safety information to the labeling of already cleared devices, the "acceptance criteria" and "study" revolve around demonstrating the device's compatibility with MRI environments, not its clinical performance as a knee implant.

1. Table of Acceptance Criteria and Reported Device Performance (for MR Safety)

Summary of Device Performance: The document states that "MR Safety testing/assessments support the appropriate MR parameters and symbols found in the subject device labeling." This implies that the devices met the requirements of the referenced ASTM and IEC standards for MR compatibility, allowing defined MR conditions (e.g., specific field strengths, gradients, RF levels) for imaging patients with these implants.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size for the MR safety testing. These tests are typically conducted on representative samples of the implant devices themselves, not on human patients.
• Data Provenance: The testing references industry standards (ASTM, IEC, ISO/TS), indicating that the tests were performed in a controlled laboratory environment in accordance with these established protocols. The country of origin of the data is not specified but is presumed to be where Smith & Nephew conducted their R&D and testing. Since it's device testing, not patient data, the retrospective/prospective distinction is not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable: For MR safety testing of physical implants, "ground truth" as established by human experts (like radiologists interpreting images) is not the primary method. The "ground truth" for MR safety is determined by the physical properties of the materials and the design of the device, measured against established engineering and safety standards. The experts involved would be engineers and physicists specializing in MRI safety and material science.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1 or 3+1 for clinical interpretations) are not relevant here. The results of MR safety testing are quantitative measurements (e.g., temperature rise, displacement force, torque, artifact size) subject to direct measurement and comparison against defined thresholds in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No: This is not applicable. MRMC studies are used to assess the impact of a diagnostic tool (like an AI algorithm) on human reader performance. This submission is about the physical safety of an implant in an MRI scanner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No: This is not applicable as there is no algorithm being tested in this submission.

7. The Type of Ground Truth Used:

• Technical Standards and Physical Measurements: The "ground truth" for MR safety is established by international and national technical standards (ASTM, IEC, ISO/TS) that define acceptable limits for magnetic force, torque, heating, and image artifact. The studies involve physical measurements of these parameters using specialized testing equipment.

8. The Sample Size for the Training Set:

• Not Applicable: There is no "training set" in the context of MR safety testing of physical implants, as this is not an AI/machine learning submission.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable: As there is no training set, this question is not relevant.

In summary, this 510(k) submission is a prime example of a regulatory clearance based on engineering and performance testing against recognized standards for physical device properties (MR compatibility), rather than clinical efficacy studies or AI performance metrics.

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The BRM Extremities NewPrim device is intended for use in:

• Hallux rigidus or hallux limitus;
• Painful rheumatoid arthritis;
• Hallux abducto valgus associated with arthritis;
• Unstable or painful joint from previous surgery

The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

The provided text is a 510(k) summary for the BRM Extremities NewPrim System, a toe joint polymer constrained prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US.

The document does not contain information about a clinical study with acceptance criteria, human readers, or ground truth for evaluating the device's performance in the context of diagnostic accuracy or clinical outcomes. Instead, it describes bench testing conducted to support substantial equivalence.

Therefore, many of your requested points cannot be answered based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document mentions two types of bench testing:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the bench tests.
• Data Provenance: This is bench testing, not clinical data from patients. The manufacturer is BRM Extremities, located in Milano, Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a prosthesis, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a prosthesis, not an AI diagnostic tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" would be the predefined engineering specifications and comparison to the predicate device's measured performance for mechanical characteristics and compliance with a standard for LAL testing. It's not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that requires a training set.

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The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The GAIT 2.0 Implants are intents presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAT Implant is a spacer that augments the Keller arthroplasty procedure by stabilizing the first metatarsal.
The SHIP Long Implants, are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.
The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impared function and stability; Pain; Impaired toe length ratio.
The SHIP Short Implants are intents presenting with the following indications commonly found in the interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Impaired function and stability; Pain; Impaired toe length ratio.

The Fusion Silastic System consists of a collection of flexible toe joint prostheses, manufactured from medical grade silicone (ASTM F2042). The product family is offered in five configurations to address varying indications and patient anatomy; the Gait Implant, the Gait 2.0 Implant, the SHIP Long Implant, the SHIP Short Implant and the Shaw Rod. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899).

This document is a 510(k) premarket notification for the Fusion Silastic System, a toe joint prosthesis. It outlines the company's claim of substantial equivalence to predicate devices.

Based on the provided document, there is NO information about acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

The document is for a physical medical device (toe joint prosthesis) and does not describe any AI component or a study to evaluate AI performance. The "Non-clinical Test Summary" and "Clinical Test Summary" explicitly state:

• Non-clinical Test Summary: "Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational was performed to show performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above."
• Clinical Test Summary: "No clinical studies were performed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria because the provided text describes a physical implant and its regulatory clearance process, not an AI-powered device.

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The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

The In2Bones USA LLC, CoLink™ Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.

The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).

The In2Bones NeoSpan® Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

The RTS® Flexible 1ST MPJ Implant w/Grommets is intended for use in the treatment of:

• · Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• · Unstable or painful joint from previous surgery

The RTS® Lesser MTP Implant is intended for use in the treatment of:

• · Partial or complete dislocation of the lesser metatarsophalangeal joint
• · Pain associated with either rheumatoid or osteoarthritis
• · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
• · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.

The In2Bones CoLink® Plating System / CoLink® View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The CoLink® Afx Plating System is a system of plates and surgical instruments used to treat traumatic fractures and osteotomies of the ankle. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) and the CoLink® View System has inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK).

The Fracture and Correction System consists of the 5MS® Plate and Screw System and the CoLag® cannulated lag screws used to treat fracture and reconstruction of the bones of the extremities. The products are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6A14V).

The RTS® Lesser MTP Implant System is a double stem silicone implant which is placed into the intramedullary canals of the first metatarsal and proximal phalangeal bones of the forefoot. The RTS® Flexible 1* MPJ Implant w/Grommets System is a flexible silicone great toe implant. Titanium grommets are also available for use in the first metatarsal (only) if the option is desired by the surgeon. The implant is used in the treatment of arthritis of the metatarsophalangeal joint. The implants are made from silicone elastomer NuSil Med 4755 from NuSil.

The In2Bones NeoSpan® Compression Staple Implant is a super elastic compression staple made of superelastic Nitinol (ASTM F2063). The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for various orthopedic implant systems. It discusses the substantial equivalence of these devices to previously cleared predicate devices, primarily based on indications, materials, and geometry.

The "Performance Testing" section states that "MR Testing per ASTM Standards (ASTM F2052, ASTM F2213, ASTM F2182 and ASTM F2119) was conducted on worst case products to cover all In2Bones product families." This refers to testing for Magnetic Resonance (MR) compatibility and labeling, not a study that proves the device meets specific acceptance criteria in a clinical or performance effectiveness context directly comparable to an AI/algorithm-based medical device.

Therefore, I cannot extract:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Information about MRMC studies, human reader improvement, or standalone algorithm performance.
5. Type of ground truth, training set size, or how its ground truth was established.

This document focuses on regulatory clearance for traditional medical devices (implants), not AI/ML-based software as a medical device (SaMD) which would typically involve the types of studies and criteria you've requested.

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The RTS® Lesser MTP Implant is intended for use in the treatment of:

• · Partial or complete dislocation of the lesser metatarsophalangeal joint
• · Pain associated with either rheumatoid or osteoarthritis
• · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
• · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.

The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials

This document is a 510(k) premarket notification for the RTS® Lesser MTP Implant System, which is a medical device. As such, the information provided does not include the detailed acceptance criteria and study data typically associated with software or AI device performance. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/software device would.

However, I can extract the information related to performance testing that was conducted to support the substantial equivalence claim for this physical implant.

1. A table of acceptance criteria and the reported device performance

Since this is a physical implant and not a software/AI device, the "acceptance criteria" are not reported in terms of metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria are implicitly met by demonstrating that the device performs equivalently to the predicate devices in terms of its physical and material properties and its ability to withstand standard sterilization, cleaning, and packaging processes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of human subjects or patient data. The performance testing refers to bench and in-vitro tests for cleaning, packaging, sterilization, and engineering analysis (Finite Element Analysis). Therefore, information on sample size, country of origin, or retrospective/prospective nature is not applicable in the way it would be for a clinical AI study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for clinical outcomes in a human study is not established here. The "ground truth" for the engineering performance and material properties would be established by standard engineering and material science methodologies, not by expert medical consensus in the way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no human "test set" or clinical adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance testing mentioned (cleaning, packaging, sterilization, engineering analysis), the "ground truth" would be established by:

• Validated laboratory protocols and standards: For cleaning, packaging, and sterilization.
• Engineering principles and material science data: For Finite Element Analysis, comparing results against established material properties and design specifications.
• Predicate device characteristics: The fundamental "ground truth" for substantial equivalence is the existing legally marketed predicate device, whose safety and effectiveness have already been established.

8. The sample size for the training set

Not applicable. This is a physical implant, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary of Device Performance (from the document):

The document states: "The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified." This overarching statement serves as the conclusion for meeting "acceptance criteria" in a 510(k) context. The specific tests performed were:

• Validations for cleaning of implants and surgical instruments.
• Validations for packaging of implants and surgical instruments.
• Validations for sterilization of implants and surgical instruments.
• Engineering analysis, including Finite Element Analysis.

The device is concluded to be substantially equivalent to the predicate devices (OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System and Integra Lesser Metatarsal Phalangeal Implant) based on similar indications, materials (Medical Grade Silicone Elastomer), and geometry.

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The RTS Flexible 1st MPJ Implant w/Grommets is intended for use in the treatment of:

• Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• Unstable or painful joint from previous surgery

The RTS Flexible 1st MPJ Implant w/Grommets is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

This document is a 510(k) premarket notification for a medical device called the "RTS Flexible 1st MPJ Implant w/Grommets." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as typically understood for a new clinical efficacy study, is largely not applicable in this context.

Here's why and what information can be extracted based on the document:

• No specific acceptance criteria or performance metrics are provided in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. This device is a surgical implant, not a diagnostic AI device. The "performance data" referred to are related to engineering, cleaning, packaging, and sterilization validation, not clinical performance metrics.
• No "study" as a clinical trial comparing device performance to acceptance criteria in the manner of an AI/diagnostic device is presented. The "study" here is essentially the demonstration of substantial equivalence.

However, I can extract the relevant information that is present in the document based on your request, highlighting where the requested details are not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes a 510(k) submission for a surgical implant, not a study involving a "test set" of data for algorithm performance. The "performance data" mentioned refers to engineering and validation testing (e.g., cleaning, packaging, sterilization), not clinical outcome data or diagnostic performance data. Therefore, there's no "sample size" or "data provenance" in the context of an AI/diagnostic algorithm test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. As above, no "test set" for expert-derived ground truth is described in this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. No test set or related adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a surgical implant, not a diagnostic AI device. Therefore, MRMC studies and concepts of human reader improvement with/without AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a surgical implant. There is no algorithm or AI component involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The "ground truth" in this context is the predicate device and its established safety and effectiveness. The current device aims to demonstrate "substantial equivalence" to this predicate, rather than generating new primary ground truth for clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not Applicable. There is no training set or associated ground truth establishment process for a training set in this submission.

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The indications for the OrthoFlex Rod include:

• Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
• Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
• Revision of a failed arthroplasty or arthrodesis

The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.

This OrthoFlex Rod 510(k) summary explicitly states that "No clinical studies were performed" and therefore no acceptance criteria or studies proving device performance against such criteria are provided in the document.

The submission focuses on establishing substantial equivalence to predicate devices based on intended use, design, material, and function, rather than demonstrating performance through clinical studies and predefined acceptance criteria.

Therefore, the requested tables and information cannot be generated from the given text.

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Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for:

• Partial or complete dislocation of the lesser metatarsophalangeal joint
• Pain Associated with rheumatoid or osteoarthritis
• Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint .
• Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• Kohler's disease
• Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state

The Lesser Metatarsal Phalangeal Joint Implant is a double-stemmed silicone prosthesis, intended to supplement lesser metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the metatarsal and base of the proximal phalanx.

This document is a 510(k) summary for a medical device called the "Lesser Metatarsal Phalangeal Joint Implant." It's a submission to the FDA (Food and Drug Administration) to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Sutter Lesser Metatarsal Phalangeal Joint Prosthesis."

The regulatory path for this device is based on substantial equivalence, not on meeting specific acceptance criteria derived from a performance study against a predefined standard. Therefore, many of the requested items, such as a table of acceptance criteria with reported device performance, sample sizes for test/training sets, expert qualifications, and study designs (MRMC, standalone), are typically associated with performance-based regulatory clearances or approvals (like de novo classification or PMA applications) rather than 510(k) submissions demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. This submission is for a medical device seeking 510(k) clearance based on substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria from a clinical or analytical study. The "acceptance criteria" here implicitly refer to demonstrating equivalence in design, materials, indications for use, and technological characteristics to the predicate device.

  The comparison provided is qualitative, highlighting similarities between the proposed device and the predicate:

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. No "test set" in the context of a clinical performance study is described. The submission focuses on comparing the proposed device's characteristics to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not Applicable. No expert-adjudicated test set is described. The "ground truth" for this 510(k) is the demonstrated similarity to the predicate device's design and intended use, as reviewed by the FDA.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or associated adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• Not Applicable. This is a device for surgical implantation, not an imaging diagnostic device that would typically undergo an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This is a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used:

• For this 510(k) submission, the "ground truth" for the substantial equivalence determination is the characteristics and performance of the legally marketed predicate device (Sutter Lesser Metatarsal Phalangeal Joint Prosthesis) combined with the design specifications and intended use of the proposed device. The evaluation relies on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate.

8. The Sample Size for the Training Set:

• Not Applicable. No "training set" in the context of an AI/ML algorithm is described.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. No training set is described.

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Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.

This submission describes the OsteoMed Interphalangeal Flexible Stabilizing Rod System intended for indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; anqular deformity; impaired function and stability; pain; impaired toe length ratio. OsteoMed Interphalangeal Flexible Stabilizing Rod Implants are intended for single use only.

The OsteoMed Interphalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the interphalangeal joints of the lesser toes. It is constructed of medical grade silicone elastomer. The OsteoMed Interphalangeal Flexible Stabilizing Rods are offered in diameters of 2.0mm through 2.5mm. Drills and sizers will also be a part of the system.

The provided document is a 510(k) summary and FDA clearance letter for a medical device, the OsteoMed Interphalangeal Flexible Stabilizing Rod System. This type of document is generally used for demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics as might be found for a novel device requiring clinical trials.

Therefore, this document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation:

The 510(k) summary explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Laboratories Shaw-Ship Rod, Hammer Toe Implant." It also notes: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Interphalangeal Flexible Stabilizing Rod System does not raise any new safety or effectiveness issues."

This indicates that the clearance was based on substantial equivalence to an already legally marketed device, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria as would be required for a device for which no predicate exists or for a higher-risk classification device. The FDA letter confirms the substantial equivalence determination.

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Indicated for partial or complete dislocation of the lesser metatarsophalangeal joint; pain associated with either rheumatoid or osteoarthritis; repair for unsuccessful arthroplasties of the lesser metatarsophalangeal joint; stiffness at the lesser metatarsophalangeal joint associated with joint disease; hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state. Implants are single use only.

The OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the lesser metatarsophalangeal joints of the foot. It is constructed of medical grade silicone elastomer. The OsteoMed Metatarsophalangeal Flexible Stabilizing Rods are offered in diameters of 2.5mm through 3.0mm. Drills and sizers will also be a part of the system.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any acceptance criteria. The document is a 510(k) summary for a medical device called the "OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System." It primarily focuses on demonstrating substantial equivalence to a predicate device (Sgarlato Lesser Toe Implant K884739) based on similarities in intended use, material, design, and operational principle.

The document does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically associated with performance studies, especially those involving AI/ML devices or novel devices requiring more extensive clinical evidence. The provided document is a regulatory submission for a device deemed substantially equivalent to a predicate, which often does not require new performance studies if the safety and effectiveness are established through the predicate.

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